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Completed

NCT Number: NCT01517607

Mesalazine (PENTASA®) in Ulcerative Colitis

This non-interventional study examines whether the patient's level of information and the consideration of the patient's preference have a positive effect on the compliance and thus also on the therapeutic success.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational site, Wettinerstraße 22, Altenburg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients are treated for the first time with oral PENTASA®, e.g. following first diagnosis of ulcerative colitis for treatment of an acute episode or
  • Following a therapy-free period (no previous mesalazine therapy) or due to poor response or underdosage oder lacking acceptance of the previous medication the patients are re-adjusted to oral PENTASA®,
  • The patients (≥ 18 years) have been informed about the NIS and have given their written consent for participation.

Treatment and study plan

Mesalazine

Other

Patient's treated with oral Mesalazine

Primary outcomes

  1. Patient compliance: Measured by patient response to a questionnaire

    Time frame: Month 0 - Month 12

Secondary outcomes

  1. Patient's level of information: Measured by patient response to a questionnaire

    Time frame: Month 0 - Month 12

  2. Patient's preference for the oral pharmaceutical form: Measured by patient response to a questionnaire

    Time frame: Month 0 - Month 12

  3. Reasons for the therapeutic decision of the physician: Measured by physician responses

    Time frame: Month 0

  4. Laboratory parameters of predefined blood measurements

    Time frame: Month 0- Month 12

    Faecal calprotectin (including test used), faecal lactoferrin. Number of leukocytes, C-reactive protein, blood sedimentation rate. Haemoglobin, serum iron, serum ferritin, transferrin saturation (TSAT)

  5. Ulcerative Colitis Disease Activity Index (UCDAI)

    Time frame: Month 0 - Month 12

    UCDAI = Blood in stool, stool frequency, overall evaluation of the physician, endoscopic evaluation (optional)

  6. Adverse drug reactions: measured by number of patients and event severity

    Time frame: Month 0 - Month 12

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Collaborators

  • Ferring Arzneimittel GmbH

Registry information

Official study title

Mesalazine (PENTASA®) in Ulcerative Colitis: Correlation of the Information Level With Patient's Compliance in Everyday Practice

Acronym: MUKOSA

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 25, 2012
Registry last updated
Oct 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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